BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM PASTE AND GELS

    MDR report key: 22802609 · Received August 14, 2025

    Report

    Report Number
    1000317571-2025-00085
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Report Date
    July 22, 2025
    Manufacturer
    CONVATEC LTD
    Product Code
    NAE
    UDI-DI
    00768455172979
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY - BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. COMPLAINT WAS RECEIVED FROM TAIWAN, PROVINCE OF CHINA REPORTING ONE UNIT OF DUODERM H/ACTIVE GEL (3TBEX30G) WITH A BROKEN SEAL. THE AFFECTED LOT WAS 4H03647 (SYSTEM APPLICATION PRODUCT (SAP) 1002859), MANUFACTURED ON 19 SEP 2024 AND STERILIZED BY (B)(4) UNDER CYCLES (B)(4) (COMPLETED 05 SEP 2024). BATCH SIZE: (B)(4) SECONDARY PACKS ((B)(4) PRIMARY). STERILIZATION WAS PERFORMED PRIOR TO FINAL PACKING. TWO PHOTOGRAPHS PROVIDED AND REVIEWED IN ACCORDANCE WITH WORK INSTRUCTIONS (WI). THE PRODUCT AND LOT NUMBER WERE CONFIRMED. THE IMAGE SHOWS THE TUBE WITH THE COLLAR STILL PRESENT. FOR THIS CONFIGURATION, THE COLLAR MUST BE REMOVED BEFORE THE CAP CAN BE TIGHTENED AND THE FOIL SEAL BROKEN. THE PRESENCE OF THE COLLAR THEREFORE DEMONSTRATES THAT THE SEAL WAS INTACT AT MANUFACTURE. THIS INDICATES THAT SUBSEQUENT TAMPERING MAY HAVE OCCURRED POST-DISTRIBUTION. NO PHYSICAL SAMPLE WAS RETURNED. A FULL BATCH RECORD REVIEW WAS COMPLETED FOR LOT 4H03647. ALL IN-PROCESS CHECKS, STAT SAMPLE INSPECTIONS, AND FINAL QUALITY CHECKS WERE FOUND SATISFACTORY. NO DEVIATIONS, REWORK, OR NON-CONFORMANCES WERE RAISED. STERILIZATION RESULTS MET SPECIFICATION AND WERE RELEASED BY ANDERSON CALEDONIA. A REVIEW OF THE TUBE AND CAP PRE-ASSEMBLY AND FILL PROCESS CONFIRMED THAT MULTIPLE OPERATOR AND AUTOMATED CHECKS ARE IN PLACE: ¿ SUPPLIER: ON RECEIPT OF TUBE + COLLAR + CAP ASSEMBLIES. ¿ AT CAP-TIGHTENING, WHERE OPERATORS VERIFY COLLAR PRESENCE AND CORRECT ENGAGEMENT. ¿ SECOND OPERATOR CHECK FOR CAP HEIGHT/FIT BEFORE TRANSPORT. ¿CONVATEC GEL FILL: OPERATORS CONFIRM COLLAR/CAP BEFORE FILLING, TUBES PASS CAP-TIGHTENING STATION AND UPSIDE-DOWN DETECTOR, FOLLOWED BY IN-LINE CHECK WEIGH. ¿ POST-FILL: OPERATORS CHECK FOR LEAKS BEFORE PACKING INTO COREX BOXES. ¿ STERILIZATION: PRE- AND POST-CHECKS CONFIRM NO DAMAGED CAPS, LEAKS, OR BURST TUBES. ANY COMPROMISED SEAL WOULD HAVE FAILED STERILIZATION DUE TO HIGH TEMPERATURE/PRESSURE. ¿ CONVATEC SECONDARY PACKAGING AT DEESIDE: MANUAL HAND-PACK WITH OPERATOR VISUAL CHECKS, IN-PROCESS QUALITY ASSURANCE (QA) CHECKS, AND FINAL INSPECTION (COUNT, LABELS, EXPIRY, INSERTS, CONTAMINATION, SHIPPER INTEGRITY). TREND REVIEW: ONE OTHER COMPLAINT HAS BEEN RECORDED FOR LOT 4H03647. ONE UNRELATED COMPLAINT WAS REPORTED DUE TO MISSING LOT AND EXPIRY ON THE SECONDARY PACKAGING. NO RELATION TO BROKEN SEAL OF TUBES. ANOTHER COMPLAINT RECORD IN DATABASE WAS RAISED FOR BATCH 4G00418. WHERE AN OPEN TUBE WAS OBSERVED WITH THE COLLAR INTACT ON THE TUBE. INDICATING POST-DISTRIBUTION TAMPERING- COMPLAINT ORIGINATED FROM MALAYSIA NO TREND ACROSS LOTS IS EVIDENT. RISK ASSESSMENT: CONFIRMED ISSUE, BUT NOT ATTRIBUTED TO DEESIDE. COLLAR STILL PRESENT, INDICATING SEAL WAS INTACT THROUGH MANUFACTURE AND STERILIZATION. NO DEVIATIONS RECORDED; STERILIZATION WOULD HAVE IDENTIFIED COMPROMISED SEALS. THE MOST LIKELY ROOT CAUSE IS TAMPERING OR DAMAGE DURING HANDLING AT THE DISTRIBUTION CENTRE OR POST-DISTRIBUTION. ACCORDING TO PROCESS INSTRUCTION (PI), THE ACCEPTABLE QUALITY LEVEL (AQL) FOR PRIMARY PACK SEAL INTEGRITY IS 0.40 (ACCEPT AT 1, REJECT AT 2 FOR 125). AT MANUFACTURE, LOT 4H03647 WAS INSPECTED AGAINST THIS PLAN AND ACCEPTED. POST-DISTRIBUTION, ONE UNIT FROM 8820 HAS BEEN REPORTED, WHICH DOES NOT REPRESENT AN AQL EXCURSION. CONCLUSION: THIS IS AN ISOLATED OCCURRENCE WITH NO IMPACT TO OTHER UNITS. NO SYSTEMIC ISSUE WAS IDENTIFIED AT DEESIDE. THE ISSUE IS MOST CONSISTENT WITH DISTRIBUTION-LEVEL TAMPERING. IN ACCORDANCE WITH WORK INSTRUCTIONS (WI), CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) IS NOT REQUIRED. THE COMPLAINT WILL BE MONITORED THROUGH ROUTINE TRENDING AND THE POST MARKET PRODUCT MONITORING REVIEW PROCESS (STANDARD OPERATING PROCEDURE (SOP). TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. MANUFACTURING SITE: 1000317571.

    Additional Manufacturer Narrative · 0

    E1: COMPLAINANT STREET ADDRESS: (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 1049092 MANUFACTURING SITE: 1000317571.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE DISTRIBUTOR AND END USER THAT THERE WAS LEAKAGE SINCE THE SEAL WAS OPENED. THE PRODUCT WAS USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1557179 DUODERM PASTE AND GELS DRESSING, WOUND, HYDROGEL WITHOUT DRUG AND/OR BIOLOGIC NAE CONVATEC LTD 187987 4H03647 00768455172979

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown